The medical device and in-vitro diagnostic medical device industry are in dire need of a robust, practical and easy to use regulatory information management (RIM) system. Without a unified and collaborative system, serious consequences to your business can occur, including an increased risk of non-compliance, increased costs as well as a possible significant reduction in a product’s revenue potential.
Missing registration dates, slow-to-market losses, and long-term, cascading impacts such as loss of customer loyalty have an immediate impact to market capitalization. Moreover, improper release of product due to lack of visibility to regulatory statuses can cause fines and loss of credibility with authorities, which can result in increased scrutiny.
Compliant product releases are required in the medical device industry. Automation that creates safeguards to prevent unintentional release of products into markets is a must. Regulators from different markets are working together to identify instances of non-compliance as well as misalignment of information in submissions and other communications. More effective control of the submission, enabled by a unified platform, can lead to a leaner, higher quality submission and a reduced regulatory burden.
Better planning and tracking in a unified system can monitor process metrics, milestones, and automatically informing submissions plan timelines with actual performance. A unified solution connects planning to execution, allowing improved, real-time process monitoring. Teams can quickly spot constraints and take action, allowing the product to get through your process faster.
Regulatory processes touch multiple functional areas. Regulatory functions have been piecing together disparate systems to achieve marginal improvement. This landscape inhibits the accurate and timely transfer of data and disruption in cross-functional workflow.
Employee turnover on regulatory teams is linked to the stress and increases greatly if team members consider processes to be inefficient or wasteful. Being able to perform one’s job efficiently and the perception of being part of a high-performing organization contributes to employee satisfaction and retention.
Having a fail-safe in place now for when (not if) your top talent leaves prevent the loss of company and product specific tribal knowledge. Retraining a new employee without the subject matter expert can cause delays and wasted time. A unified system keeps all information within the company.